FDA UDI
In Commercial Distribution
🇺🇸 United States
Anti-Human Globulin Anti-IgG - Clear
DI: 23661562105490
·
Model: 210549
·
DIAGAST
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
Basic Information
- Brand Name
- Anti-Human Globulin Anti-IgG - Clear
- Primary DI
- 23661562105490
- Version / Model
- 210549
- Catalog Number
- 210549
- Company Name
- DIAGAST
- Labeler DUNS
- 381527001
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2018-05-01
- Public Version
- 3
- Public Version Date
- 2021-05-24
- Public Version Status
- Update
- Public Device Record Key
- 5f164da7-38e5-4284-b99e-9dfc289219da
Device Description
Anti-Human Globulin Anti-IgG (Murine Monoclonal) (18833+18896) is intended for use in the direct antiglobulin test to detect in vivo coating on human red blood cells with IgG and for the indirect antiglobulin test for antibody screening and identification, and crossmatch and for erythrocyte phenotyping with blood phenotyping reagents requiring an indirect antiglobulin test method.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46948 | Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody | One or multiple immunoglobulins capable of binding to human antibodies from immunoglobulin class G (IgG) that are fixed to red blood cell antigens. This immunoglobulin, known as monospecific immunoglobulin G antihuman globulin (IgG AHG) is intended to be used in immunohaematological testing of a clinical specimen to detect red blood cell sensitization by human IgG, using an agglutination or solid-phase red blood cell adherence method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 23661562105490 | GS1 | ||||
| Unit of Use | 13661562105493 | GS1 |
Customer Contacts
- Phone
- (800) 452-6877
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius